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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002272-24 | EudraCT Number |
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The purpose of this study was to compare the safety and efficacy of ABT-493/ABT-530 to the combination of sofosbuvir (SOF) and daclatasvir (DCV) in adults with genotype 3 (GT3) chronic hepatitis C virus (HCV) infection.
This study was a Phase 3, randomized, open-label, active-controlled multicenter study to compare efficacy and safety of ABT-493/ABT-530 to SOF and DCV in treatment-naïve chronic HCV GT3-infected participants without cirrhosis. The study consisted of 2 periods, a treatment period (participants received 8 or 12 weeks of ABT-493/ABT-530 or 12 weeks of SOF with DCV) and a post-treatment period (participants who completed or prematurely discontinued the treatment period were followed for 24 weeks after their last dose of study drug to evaluate efficacy and to monitor HCV RNA and the emergence and persistence of viral variants).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
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| Arm B | Active Comparator | Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks. |
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| Arm C | Experimental | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-493/ABT-530 | Drug | Tablet; ABT-493 coformulated with ABT-530 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | 12 weeks after the last actual dose of study drug |
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A | SVR12 was defined as plasma HCV RNA level \ | 12 weeks after the last actual dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B | SVR12 was defined as plasma HCV RNA level \ | 12 weeks after the last actual dose of study drug |
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Inclusion Criteria:
Male or female (of nonchildbearing potential, practicing total abstinence, sexually active with female partners only, or using allowed contraceptive methods) at least 18 years of age at time of screening.
Screening laboratory result indicating HCV GT3 infection.
Chronic HCV infection, defined as one of the following:
Hepatitis C virus treatment-naïve (i.e., participant had never received any anti-HCV treatment).
Documented as noncirrhotic.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29365309 | Background | Zeuzem S, Foster GR, Wang S, Asatryan A, Gane E, Feld JJ, Asselah T, Bourliere M, Ruane PJ, Wedemeyer H, Pol S, Flisiak R, Poordad F, Chuang WL, Stedman CA, Flamm S, Kwo P, Dore GJ, Sepulveda-Arzola G, Roberts SK, Soto-Malave R, Kaita K, Puoti M, Vierling J, Tam E, Vargas HE, Bruck R, Fuster F, Paik SW, Felizarta F, Kort J, Fu B, Liu R, Ng TI, Pilot-Matias T, Lin CW, Trinh R, Mensa FJ. Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. N Engl J Med. 2018 Jan 25;378(4):354-369. doi: 10.1056/NEJMoa1702417. | |
| 31568620 |
| Label | URL |
|---|---|
| Related info | View source |
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A total of 506 participants were randomized and 505 received ≥ 1 dose of study drug. One participant in Arm B was randomized in error and never dispensed study drug. This participant is included in the total number of participants in Arm B who discontinued the study. This study included a 42-day screening period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
| FG001 | Arm B | Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sofosbuvir | Drug | Tablet |
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| Daclatasvir | Drug | Tablet |
|
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| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. | Treatment weeks 1, 2, 4, 8 (end of treatment for Arm C), and 12 (end of treatment for Arms A and B) or premature discontinuation from treatment |
| Percentage of Participants With Post-treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection. | From the end of treatment through 12 weeks after the last dose of study drug |
| Derived |
| Brown A, Welzel TM, Conway B, Negro F, Brau N, Grebely J, Puoti M, Aghemo A, Kleine H, Pugatch D, Mensa FJ, Chen YJ, Lei Y, Lawitz E, Asselah T. Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials. Liver Int. 2020 Apr;40(4):778-786. doi: 10.1111/liv.14266. Epub 2019 Oct 18. |
| 30977945 | Derived | Back D, Belperio P, Bondin M, Negro F, Talal AH, Park C, Zhang Z, Pinsky B, Crown E, Mensa FJ, Marra F. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis. J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20. |
| 30923816 | Derived | Gane E, Poordad F, Zadeikis N, Valdes J, Lin CW, Liu W, Asatryan A, Wang S, Stedman C, Greenbloom S, Nguyen T, Elkhashab M, Worns MA, Tran A, Mulkay JP, Setze C, Yu Y, Pilot-Matias T, Porcalla A, Mensa FJ. Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease. Clin Infect Dis. 2019 Oct 30;69(10):1657-1664. doi: 10.1093/cid/ciz022. |
| 30529905 | Derived | Foster GR, Dore GJ, Wang S, Grebely J, Sherman KE, Baumgarten A, Conway B, Jackson D, Asselah T, Gschwantler M, Tomasiewicz K, Aguilar H, Asatryan A, Hu Y, Mensa FJ. Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies. Drug Alcohol Depend. 2019 Jan 1;194:487-494. doi: 10.1016/j.drugalcdep.2018.11.007. Epub 2018 Nov 24. |
| 30012435 | Derived | Flamm S, Reddy KR, Zadeikis N, Hassanein T, Bacon BR, Maieron A, Zeuzem S, Bourliere M, Calleja JL, Kosloski MP, Oberoi RK, Lin CW, Yu Y, Lovell S, Semizarov D, Mensa FJ. Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection. Clin Gastroenterol Hepatol. 2019 Feb;17(3):527-535.e6. doi: 10.1016/j.cgh.2018.07.003. Epub 2018 Sep 10. |
| FG002 | Arm C | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks. |
| Received Study Drug |
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| Completed Study Drug |
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| Discontinued Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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All participants who received at least 1 dose of study drug (safety population)
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
| BG001 | Arm B | Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks. |
| BG002 | Arm C | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were counted as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
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| Primary | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A | SVR12 was defined as plasma HCV RNA level \ | All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
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| Secondary | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B | SVR12 was defined as plasma HCV RNA level \ | All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
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| Secondary | Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. | All participants who received at least 1 dose of study drug (ITT population) | Posted | Number | 95% Confidence Interval | percentage of participants | Treatment weeks 1, 2, 4, 8 (end of treatment for Arm C), and 12 (end of treatment for Arms A and B) or premature discontinuation from treatment |
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| Secondary | Percentage of Participants With Post-treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection. | All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA \ | Posted | Number | 95% Confidence Interval | percentage of participants | From the end of treatment through 12 weeks after the last dose of study drug |
|
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Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. | 5 | 233 | 126 | 233 | ||
| EG001 | ARM B | Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks. | 2 | 115 | 53 | 115 | ||
| EG002 | ARM C | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks. | 3 | 157 | 64 | 157 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ULCERATIVE KERATITIS | Eye disorders | MedDRA v.19.0 | Systematic Assessment |
| |
| OPHTHALMIC HERPES SIMPLEX | Infections and infestations | MedDRA v.19.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA v.19.0 | Systematic Assessment |
| |
| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA v.19.0 | Systematic Assessment |
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| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA v.19.0 | Systematic Assessment |
| |
| POISONING | Injury, poisoning and procedural complications | MedDRA v.19.0 | Systematic Assessment |
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| IRON DEFICIENCY | Metabolism and nutrition disorders | MedDRA v.19.0 | Systematic Assessment |
| |
| PARANASAL SINUS AND NASAL CAVITY MALIGNANT NEOPLASM RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v.19.0 | Systematic Assessment |
| |
| ABORTION MISSED | Pregnancy, puerperium and perinatal conditions | MedDRA v.19.0 | Systematic Assessment |
| |
| DEPENDENCE | Psychiatric disorders | MedDRA v.19.0 | Systematic Assessment |
| |
| SUBSTANCE-INDUCED PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA v.19.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA v.19.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA v.19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA v.19.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA v.19.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA v.19.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA v.19.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA v.19.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA v.19.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v.19.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA v.19.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA v.19.0 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000612853 | glecaprevir |
| C000622691 | pibrentasvir |
| C000654128 | glecaprevir and pibrentasvir |
| D000069474 | Sofosbuvir |
| C549273 | daclatasvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
Not provided
Not provided
| Male |
|
| percentage of participants | 95.3 | 2-Sided | 97.5 | 92.2 | 98.4 | Non-Inferiority | Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%. |
| Difference in SVR12 rates (Arm A - Arm B). | Difference in percentage of participants | -1.2 | 2-Sided | 97.5 | -6.2 | 3.7 | Non-Inferiority | Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%. |
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
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| Units |
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